FDA.reportPublic FDA data

Robaxin

Product NDC
52244-449
Requested package NDC
52244-449-10
11-digit product format
522440449
Labeler code
52244
Product ID
52244-449_53a60c30-a22d-42ce-8bca-761bb30f5b29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methocarbamol
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Endo Pharmaceuticals Inc.
Application
NDA011011
Marketing category
NDA
Marketing start
2011-08-18
Marketing end
2021-03-31
Substance
METHOCARBAMOL
Active strength
750 mg/1
Pharmacologic classes
Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage52244-44952244-449-10DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N011011-004ROBAXINMETHOCARBAMOL500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982
N011011-006ROBAXIN-750METHOCARBAMOL750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N011011-004ROBAXIN500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-08-01 22:54:322026-06N011011-006ROBAXIN-750750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52244-449-10EA - Each52244-4490b4ce1c0-c6a0-474a-b7fe-831fa30d6e0f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MethocarbamolACTIVE INGREDIENT125OD7737XROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
MethocarbamolACTIVE MOIETY125OD7737XROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROBAXIN (METHOCARBAMOL) TABLET, FILM COATED [ACTIENT PHARMACEUTICALS, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52244-449-1052244044910100 TABLET, FILM COATED in 1 BOTTLE (52244-449-10) 2011-08-182021-03-31NoNoCurrent